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IT Infrastructure Qualification: Keeping GxP Firms Tech-Compliant

March 26th, 2014 by

IT InfrastructureMedical device manufacturers and pharmaceutical companies use advanced IT tools to maintain sensitive business information, manufacture products and establish valid Quality Systems. In the past data integrity has been an important topic and is an increasingly important focus for FDA and EU regulators. The architectures employed by life sciences firms must be designed to facilitate consistent oversight and well-maintained compliance.

Because these data structures are often complex, many [...] Read More

Quantifying The Value Of An FDA Mock Audit For Medical Device Manufacturers

March 21st, 2014 by

FDA Mock AuditFDA and ISO inspections are extremely stressful, but they play vital roles in your market viability. Even if you [...] Read More

Using Audits To Improve Your Supplier Quality And Performance

March 19th, 2014 by

Supplier AuditsSupplier oversight and quality is imperative in maintaining the integrity of your product as well as your brand. When done correctly by knowledgeable and experienced consultants, [...] Read More

FDA Demands Full Compliance With GMP Requirements in the Pharmaceutical Industry – To What Extent Is Compliance Required?

March 12th, 2014 by

Pharmaceutical Production ComplianceThe most succinct answer to the question of what determines FDA compliance with GMP regulations of pharmaceutical production is adherence to 21 CFR Part 210 and 211. Anything less than complete adherence will render [...] Read More

The European Medical Device Directive As It Compares To 21 CFR 820

March 10th, 2014 by

FDA & EU Medical Device ComplianceThe European Medical Device Directive or 93/42/EEC regulates which medical devices may be sold in the European market, while 21 CFR 820 is an FDA Quality Systems Regulation is a document that helps manufacturers of medical devices establish and follow a quality system within their [...] Read More

Risk and Supply Chain Security – Meeting the Demand for Compliance

March 6th, 2014 by

Pharmaceutical Lab EquipmentCompanies which manufacture and distribute pharmaceuticals in domestic or international markets face more scrutiny than ever from regulating authorities, including the FDA and European Regulatory Authorities. Much of this scrutiny revolves around drug safety, also known as pharmacovigilance.

Appropriate and effective risk management and supply chain safety and security protocols are vital for FDA and EU compliance. There [...] Read More

Cybersecurity Regulations in a GxP Environment

March 4th, 2014 by

Medical Device Cyber SecurityModern medical devices bear an increased capacity for advanced data processing. In addition to being able to store far greater quantities of patient information than they once [...] Read More